AMIODARONE for Off label use: Side Effects & Safety Data
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There are 158 adverse event reports in the FDA FAERS database where AMIODARONE was used for Off label use.
Most Reported Side Effects for AMIODARONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 2,223 | 8.8% | 317 | 1,280 |
| Dyspnoea | 2,182 | 8.7% | 458 | 1,300 |
| Off label use | 1,608 | 6.4% | 513 | 872 |
| Drug interaction | 1,589 | 6.3% | 156 | 992 |
| Asthenia | 1,452 | 5.8% | 327 | 714 |
| Interstitial lung disease | 1,421 | 5.7% | 388 | 939 |
| Hyperthyroidism | 1,410 | 5.6% | 119 | 883 |
| Fatigue | 1,269 | 5.1% | 282 | 532 |
| Bradycardia | 1,261 | 5.0% | 106 | 877 |
| Atrial fibrillation | 1,211 | 4.8% | 172 | 836 |
| Hypotension | 1,090 | 4.3% | 180 | 795 |
| Dizziness | 1,041 | 4.1% | 79 | 477 |
| Electrocardiogram qt prolonged | 1,000 | 4.0% | 54 | 565 |
| Cough | 997 | 4.0% | 242 | 474 |
| Toxicity to various agents | 960 | 3.8% | 258 | 591 |
Other Indications for AMIODARONE
Atrial fibrillation (9,083)
Product used for unknown indication (5,365)
Ventricular tachycardia (1,692)
Arrhythmia (1,681)
Ventricular fibrillation (658)
Atrial flutter (441)
Supraventricular tachycardia (341)
Tachycardia (282)
Drug therapy (280)
Cardiac disorder (256)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)